Atraumatic wound care and closure system

ABSTRACT

An article useful for atraumatic care and/or closure of wounds, as well as for repairing torn or ripped fabric is provided. The article comprises a substrate having opposing first and second major surfaces, a plurality of raised anchoring members disposed across the first major surface, and an optional adhesive pre-mounted adjacent the second major surface. A separate adhesive could also be used to mount the article to the desired underlying surface to be repaired. The substrate is a flexible and conformal continuous web that can be cut into pieces to custom fit the wound or fabric opening. Using the anchoring members and a thread, the pieces can be drawn together to correspondingly draw the tissue or fabric on either side(s) of the opening together, thereby closing the opening without piercing or suturing/sewing together the underlying tissue or fabric. Methods for the atraumatic care and/or closure of wounds, as well as for repairing torn or ripped fabric are also provided, including kits to facilitate the same.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/342,322, which is the U.S. National Stage ofPCT/US2013/051878, filed Jul. 24, 2013, which claims the prioritybenefit of PCT/US2013/031502, filed Mar. 14, 2013, and U.S. ProvisionalPatent Application Ser. No. 61/756,931, filed Jan. 25, 2013, eachentitled ATRAUMATIC WOUND CARE AND CLOSURE SYSTEM, and incorporated byreference in its entirety herein.

BACKGROUND

Field of the Invention

The present disclosure relates to an article, system, and method for theclosure of wounds, tears, and rips, without piercing the underlying torntissue or fabric.

Description of Related Art

Traditional wound closure techniques involve the use of sutures,commonly known as stitches, while more modern techniques utilizestaples, adhesives, hemostats, and/or sealants. The primary function ofa wound closure device or technique is to close a wound, both internaland external, and stop the bleeding through hemostasis. And importantsecondary function that wound closure techniques are expected to performis avoiding or minimizing scarring. Scarring is particularly relevantwith respect to facial wounds, as well as in cosmetic surgeryprocedures. Another problem posed by tissue wounds is the fact that manywounds are not straight cuts on a flat surface. Rather, living bodiesare curved and contoured, and wounds are typically irregular. Forexample, stellate lacerations contain several V-shaped openings, whereinthe tip of the V has already been compromised. Using a suture or staplethrough that tissue will only further compromise the tissue and theblood supply. Thus, even current wound closure techniques sufferdrawbacks and there remains a need in the art for wound closuretechniques that avoid further traumatization to the wound tissue.

SUMMARY

The present disclosure is broadly concerned with an article for theatraumatic closure of a wound, atraumatic securement of medical devices,and/or general atraumatic wound care. The article is also useful for theclosure of ripped or torn fabric. The article is particularly useful forthe treatment, care, and/or closure of open wounds, such as abrasions,burns, incisions, lacerations/tears, punctures, avulsions, and the like.In general, the article comprises a substrate having opposing first andsecond major surfaces, a plurality of raised thread-receiving orthread-securing anchoring members disposed across the first majorsurface, and an optional adhesive adjacent (i.e., face-to-face contactwith) the second major surface. The adhesive is operable for securingthe article to the tissue or fabric to be repaired and can be providedalready mounted to the article. Alternatively, the adhesive can beseparately provided and first applied to the tissue or fabric, followedby securing the article to the tissue or fabric with the second majorsurface adjacent (i.e., face-to-face contact with) the adhesive.

A system for atraumatic wound care and/or closure is also provided. Thesystem comprises an article useful for atraumatic closure of a wound, asdescribed herein, and a thread.

A method for the atraumatic closure of a tissue wound of a subject isalso disclosed. The wound has wound edges, and the method generallycomprises providing an article useful for atraumatic closure of a wound,as described herein, and a thread. The article substrate is adhered tothe subject's tissue adjacent (i.e., next to) the wound edges on a firstside of the wound and a second side of the wound opposite the firstside. The wound edges are then reapproximated. Wound reapproximation iscarried out by realigning the disrupted tissue planes by securing thethread to a first anchoring member on the first side of the wound,passing the thread to the second side of the wound opposite the firstside and securing the thread to a second anchoring member. This processis repeated along the edges of the wound keeping the thread undertension to pull the tissue from the first side of the wound towards thetissue on the second side of the wound thereby ultimately closing thewound.

The present disclosure is also concerned with a kit for the atraumaticclosure of a wound. The kit comprises an article useful for atraumaticclosure of a wound, as described herein, and optionally a thread, andadhesive, along with instructions for using the article and a thread toclose a wound

A method for the atraumatic care of a wound of a subject is alsodisclosed herein. The wound has wound edges, and the method generallycomprises providing an article useful for atraumatic care of a wound, asdescribed herein, and a thread. The article substrate is adhered to thesubject's tissue adjacent (i.e., next to) the wound edges on a firstside of the wound and a second side of the wound opposite the firstside. The wound (which can optionally be packed and/or covered with askin graft) is covered with a dressing. The dressing is then secured tothe wound by securing the thread to a first anchoring member on thefirst side of the wound, passing the thread over the dressing to thesecond side of the wound opposite the first side and securing the threadto a second anchoring member. This process is repeated along the woundedges keeping the thread under sufficient tension to press the dressingtowards the wound and frictionally secure it to the wound.Alternatively, the thread can be passed through the dressing foradditional stability and securement.

The present disclosure is also concerned with a method for theatraumatic securement of a medical device to a patient's tissue usingthe inventive system. The method generally comprises providing anarticle useful for atraumatic care of a wound, as described herein, anda thread. A medical device is inserted into the patient. The articlesubstrate is adhered to the patient's tissue adjacent (i.e., next to)where the device has been inserted into the patient on a first side ofthe device and on a second side of the device opposite the first side. Athread is secured to a first anchoring member on the first side of thedevice and also to the device itself A thread (same or different) isalso secured to a second anchoring member on the second side of thedevice and to the device itself The thread on each side of the device isunder opposing forces (tension), which stabilizes the device andprevents dislodgement of the device from the patient.

A method of repairing torn or ripped fabric on a stuffed toy is alsodisclosed herein. The toy comprises an opening in the fabriccorresponding to a tear or rip, and has opening edges. The methodcomprises providing an article useful for repairing torn or rippedfabric, as described herein, and a thread. The article substrate isadhered to the fabric adjacent (i.e., next to) the edges on a first sideof the tear or rip and a second side of the tear or rip opposite thefirst side. The opening edges are brought together by securing thethread to a first anchoring member on the first side of the tear or rip,passing the thread to the second side of the tear or rip opposite thefirst side and securing the thread to a second anchoring member. Thisprocess is repeated along the opening edges, keeping the thread undertension to pull the fabric from the first side of the tear or riptowards the fabric on the second side of the tear or rip thereby closingthe opening and repairing the torn or ripped fabric.

A kit for repairing torn or ripped fabric on a stuffed toy is alsodescribed herein. The kit comprises an article useful for repairing tornor ripped fabric, as described herein, and optionally a thread andadhesive, along with instructions for using the article and a thread toclose the opening and repair the fabric.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of one embodiment of the atraumatic woundcare and/or closure system, including thread;

FIG. 2a is an illustration of a stellate laceration;

FIG. 2b is a perspective view of one embodiment of the atraumatic woundcare and/or closure substrate article severed into pieces and adhered totissue adjacent (i.e., next to) the stellate laceration edges;

FIG. 3 is a further perspective view of one embodiment of the atraumaticwound care and/or closure substrate article severed into pieces andadhered to tissue adjacent (i.e., next to) the edges of a v-shapedwound;

FIG. 4a is a top plan view of one embodiment of the atraumatic woundcare and/or closure system and a wound closed by passing the thread backand forth across the wound to reapproximate the wound edges;

FIG. 4b is a top plan view of the system illustrating further threadingto reinforce the system;

FIG. 5a is a cross-section illustration of an inverted wound edge;

FIG. 5b is a cross-section illustration of the wound edges being evertedusing the system;

FIG. 6 illustrates a further embodiment of the wound care and/or closurearticle;

FIG. 7a is a perspective view an IV tube inserted in a subject's armthat is secured to the patient using the system;

FIG. 7b is a side elevational view of a patient that has been intubated,wherein the tube is secured to the patient using the system;

FIG. 8a illustrates an open wound filled with sterile packing material,with a portion of the packing external to the wound secured to the woundcare substrate;

FIG. 8b illustrates a dressing secured over a wound using the system;

FIG. 9 illustrates a process of grafting a burn wound and then securinga bolster dressing over the wound using the system; and

FIG. 10 illustrates use of system to secure a pressure dressing over awound.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present disclosure is concerned with a wound care and/or closuresystem for atraumatic care and/or closure of wounds. The term“atraumatic” is used herein to denote that the wound care and/or closuresystem involves no penetration or piercing of the subject's tissue, forexample with a needle, staples, or other conventional suturing or woundclosure techniques. With reference to FIG. 1, the wound care and/orclosure system 10 comprises an article substrate 12 and optionally athread 14. The substrate 12 comprises first and second opposing majorsurfaces, referred to herein as a front surface 16 and a back surface18, respectively. The substrate 12 comprises a continuous web or sheetthat is flexible in all directions and conformal to underlying surfacesto which the substrate 12 may be applied, such as for example,conformable topical application to human or animal skin The substrate 12can be provided in various shapes and sizes, including an elongatedsheet, rectangular, circular, triangular, or other shape. For example,the substrate 14 can have a pair of laterally-spaced longitudinal sideedges 12 a and a pair of laterally spaced transverse ends 12 b, defininga substantially rectangular or square shape, as depicted in FIG. 1. Inother embodiments, the substrate 12 can have an annular lateral edgedefining a substantially circular shape or three lateral edges forming atriangular shape (not shown).

The substrate 12 may be a woven or nonwoven web (also referred to in themedical tape art as a backing), and may be composed of natural,synthetic, or a combination thereof of fibers. Examples of naturalfibers include cotton, silk, hemp, flax, and the like. Examples ofsynthetic fibers include rayon, polyester, acrylic, acrylate,polyolefin, nylon, polyurethane, polyethylene, polypropylene, polyamide,polytetrafluoroethylene, wire mesh, embedded wire clothe (e.g.,butterfly tape), and the like. The substrate 12 may also be a laminatedor extruded sheet. Foam substrates 12 may also be used. In someembodiments, the substrate materials are preferably biocompatible. Insome embodiments, the substrate comprises a woven or nonwoven breathablematerial. In one or more embodiments, the substrate is preferablysubstantially free of metals or other rigid materials. It will beappreciated that materials conventionally useful as backing for medicaltapes and dressings are particularly suitable for use as the substratematerial. Some exemplary tapes include those available from 3M: KindRemoval Silicon Tape, Medipore Cloth Tape, Transpore White Tape,Micropore, Durapore, Blenderm, and the like. In some embodiments, theweb itself may be comprised of multiple layers (i.e., multilayered). Theaverage thickness of the substrate 12 will generally range from about 1mil (0.001 inch) to about 10 mil (0.010 inch), preferably from about 1mil to about 5 mil, and more preferably from about 2 mil to about 5 mil.The thickness of the substrate 12 preferably has little variation acrossthe expanse of the substrate. In other words, the thickness of thesubstrate is preferably substantially uniform as measured between thefirst and second major surfaces edge-to-edge. A significant advantage ofthe inventive substrate is that it is severable 12. As used herein, theterm “severable” means that the substrate 12 can be cross-sectionallytorn or cut into one or more pieces that conform to the shape of thewound opening to be closed. In other words, the term is directed towardscutting through the substrate 12 along a plane that cuts across (and ispreferably generally perpendicular to) the plane defined by the frontand back surfaces, and does not encompass separating the substrate alongthe plane defined by the front and back surfaces (for example, pullingapart layers in a multilayered substrate).

The front surface 16 of the substrate 12 comprises a plurality of raisedanchoring members 20. The anchoring members 20 are disposed across thesurface 16 and generally project away from the front surface 16 suchthat they are adapted to receive and secure (i.e., anchor) a thread 14when the system 10 is in use (i.e., when the thread 14 is looped aroundor threaded through the anchoring members 20). In general, the anchoringmembers 20 will have respective heights, as measured from the frontsurface 16 of from about 1 mm to about 20 mm, preferably from about 2 mmto about 10 mm, and more preferably from about 2 mm to about 5 mm.Exemplary anchoring members include generally upright loops orhalf-loops, eyelets, raised or pleated mesh, hooks, pegs, prongs, nubs,generally upright strands of fiber (e.g., yarn), prone strands of fiber(e.g., yarn), generally upright pleats, or other protrusions that arecomprised either of penetrable materials (e.g., rubber, plastic,composite, etc.) or configured to be looped around. For example, in someembodiments, the protrusions have a head and a throat around which thethread is wrapped whereby the head prevents the thread from disengagingthe protrusion. The head may be angled to improve anchoring. In otherembodiments, the protrusions are penetrable and adapted for passing thethread 14 through the protrusion itself (in one side and out the other),thereby anchoring the thread 14 to the front surface 16. In yet otherembodiments, the anchoring member is an aperture, such as a loop, meshopening, or eyelet, through which the thread 14 can be guided. Loops orhalf-loops can be formed by securing an elongated cord (or individualcord pieces) to the front surface 16 at various intervals across thesurface to create a plurality of loops or half-loops as depicted inFIG. 1. The anchoring members 20 are each attached or secured to thesubstrate as appropriate for the particular anchoring member. Forexample, the anchoring members 20 can be sewn to or through thesubstrate, glued, tied, and the like. In some embodiments, the anchoringmembers 20 are integrally formed with the substrate 12. For example, thefront surface 16 of the substrate 12 may be pleated, such that thepleats form anchoring members 20, which are formed of the same materialas the substrate 12 itself (instead of being a separate piece that issubsequently attached thereto).

Particularly preferred anchoring member 20 configurations helpdistribute the pulling forces across the expanse of the substrate, suchthat the pulling force is not localized to any one area of tissue, asoccurs with traditional suturing. In one or more embodiments, theanchoring members 20 will be disposed substantially uniformly across thefront surface 16, for example as in a grid or matrix pattern. In otherwords, the density (number) of anchoring members 20 in a first portionof the front surface 16 will be substantially equivalent to the densityof anchoring members 20 in a second, different portion of the frontsurface 16 having the same surface area. In one or more embodiments, theanchoring members 20 will be disposed in individual, separated groupingsacross the surface, which have spaces therebetween. In one or moreembodiments, the anchoring members 20 will be randomly disposed acrossthe surface 16.

It will be appreciated that the front surface 16 can comprise the sametype of anchoring member 20 across the surface. Alternatively, more thanone type of the above-described anchoring members 20 can be used acrossthe face of the front surface 16. Combinations of the above describedmaterials can also be used to form the anchoring members 20. Forexample, a plurality of raised anchoring members (e.g., prone strands ofyarn, nubs, etc.) can be covered with a substantially conformal layer ofmesh. In use, the thread 14 can be guided through an opening in the meshas well as through the corresponding raised anchoring member and out theother side through a corresponding opening in the mesh. Such anembodiment is depicted in FIG. 6.

The back surface 18 of the substrate 12 is configured to engage orcontact an underlying surface, such as tissue or fabric to be repaired.The substrate 12 is attached to the underlying surface via an adhesive(aka glue) interposed between the back surface 18 of the substrate 12and this underlying surface. In one or more embodiments, the adhesive isprovided separately from the article 10. The adhesive is dispensed orapplied onto the underlying surface, followed by mounting or attachingthe article to the underlying surface with the back surface 18 of thesubstrate 12 adjacent (i.e., in face-to-face contact with) the adhesive.In one or more embodiments, the back surface 18 of the substrate 12comprises an adhesive (or layer of adhesive) pre-mounted to the backsurface 18, which can be in the form of a layer adjacent (i.e., inface-to-face contact with) the back surface 18. In one or moreembodiments, the adhesive covers substantially the entire surface areaof the back surface 18. In one or more embodiments, the peripheralmargins of the back surface 18 remain substantially free of adhesive.

Regardless of the embodiment, suitable adhesives include pressuresensitive adhesives, as well as heat- or radiation-activated adhesives.It will be appreciated that the appropriate adhesive will depend uponthe ultimate intended use of the system 10. For example, if thesubstrate 12 will be topically applied to skin, the adhesive should havegood initial tack and long-term adhesion, and be able to tolerate thepresence of moisture without releasing. Pressure-sensitive adhesivesgenerally comprise elastomers that are inherently tacky or includetackifying resins. Exemplary adhesives for use in the invention includerubber elastomers, acrylics, acrylates (e.g., cyanoacrylates), epoxies,silicones, zinc oxides (or other hot melt adhesives), solvent-basedadhesives, solvent-free adhesives, photosensitive adhesives,hydrocolloids, hydrogels, polyurethanes, styrene block co-polymers, andthe like. In some embodiments, the adhesive is biocompatible. Numeroustypes of suitable adhesives are known in the art, and arecommercially-available from suppliers such as 3M, Loctite (e.g.,Duro-Tak), Adhesives Research, Ashland Chemical (e.g., Aroset), Dow(e.g., Robond), Polymer Science (e.g., Sofsil, Neosil), DuPont, and ITWFormex. Particularly preferred adhesives will have strong tissueadhesion properties, and adhesives suitable for use in medical tapes anddressings are preferred in some embodiments of the invention. Forexample, zinc oxide is currently considered a preferred adhesive forextreme adhesion needs. Low trauma adhesives can also be used.

The substrate 12 can be provided as one or more sheets or strips, eachwith a releasable liner covering the adhesive (when present) to preventindiscriminate adherence or sticking of the substrate 12 to an undesiredsurface and/or preserve the adhesive properties of the adhesive layerand/or protect the adhesive layer from attracting dirt, debris, and thelike until use. In some embodiments, the substrate 12 can be anelongated strip wound about a spool or dispensing apparatus. In one ormore embodiments, the substrate 12 is provided as a large sheet that canbe cut down to the necessary size. For example, dimensions such as 30cm×30 cm are envisioned.

The thread (aka string, lace, cord, etc.) 14 can be any suitable type ofelongated, woven or extruded threading material, such as cotton, nylon,polyester, polypropylene, silk, wire, stainless steel, plastic, cable(e.g., zip ties), and the like. Conventional suturing threads (2 mm orless, preferably 1 mm or less, more preferably 0.5 mm or less indiameter) are suitable for use with the invention (whether or notspecifically provided for use with the system). The thread could becoated or uncoated. A needle (not shown) can be included for guiding thethread 14. A conventional metal needle may be used; however, since thesystem does not involve piercing the subject's skin, the needle may alsobe plastic or other suitably rigid material for guiding the thread 14that is otherwise not sufficiently sharp or rigid to pierce skin tissue.Alternatively, the thread 14 itself can be provided with a substantiallyrigid end portion (at one or both ends) to facilitate feeding the threadthrough the anchoring members. The end portion of the thread can be maderigid by any suitable method, including the use of wax, resin,composite, glue, heat shrink, or melting the end portion of the thread.In some embodiments, the substantially rigid portion is a plastic ormetal sheath (i.e., aglet) around the end portion of the thread. In someembodiments, the entire length of the thread is of sufficient rigidityto guide the thread through and/or around the anchoring members, such asin the case of wire or some plastic threads.

The inventive substrate 12 is particularly advantageous for theatraumatic closure of wounds, as mentioned above. In one or moreembodiments, a substrate 12 according to the invention is provided foruse with a subject having a wound 100. The term wound is used herein torefer to injury or disruption to living tissue caused by a cut, blow, orother impact in which the skin is cut or broken, as well as to incisions(such as surgical incisions) into the skin Thus, the term encompassesincisions, cuts, lacerations, burns, avulsions, necrosis, and the likeof the skin (epidermis). Wounds can follow substantially straight lines,but are generally of irregular shape and contour depending upon thelocation of the body where the wound occurs. Stellate lacerations, whichare illustrated in FIGS. 2a -2 b, pose a particular problem fortraditional suturing techniques. In one or more embodiments, a templatecan be used to determine the shape of the wound 12. For example, tissuepaper or a like absorbent material (e.g., copy paper, cellulosicmaterials) can be pressed gently against the wound whereby the tissuepaper absorbs fluid from the wound and provides an approximate shape forthe wound. This shape is then transferred to the substrate 12. Aparticular advantage of the invention is that the substrate 12 can becut (e.g., with scissors or a knife) to custom fit the wound 100. Asshown in FIG. 2b , the severed pieces of the substrate 12 are thenplaced on (and adhered to) the skin of the subject, adjacent (i.e., nextto and sharing a common border with) the wound edges 102, either usingseparately-applied adhesive or adhesive pre-mounted to the substrate 12.As noted above, the substrate 12 may first need to be released from thereleasable liner to expose the adhesive layer, when pre-mounted onto thesubstrate. In some embodiments, to enhance adhesion, the tissue of thesubject can be prepared before applying the substrate 12 or adhesive.Suitable skin preparation techniques include wiping the skin around andnear the wound area with isopropyl alcohol (e.g., Preppies Skin BarrierWipes; Kendall), betadine, chlorhexidine, and the like.

In some embodiments, the system 10 can further comprise an adhesiveunderlayment or intermediate layer (not shown) to which the substrate 12is applied, instead of being applied directly to the tissue adjacent(i.e., next to) the wound. For example, an adhesive-backed substrate(e.g., medical tape) that includes a sufficiently strong adhesive forskin contact is applied to the subject. The substrate 12 is then appliedto the adhesive-backed substrate to bond the substrate to the adhesiveunderlayment, rather than directly to the tissue of the subject. Anexample of this type of system is Rigid™ strapping tape, which istypically used for athletic immobilization.

Regardless of the embodiment, once the piece or pieces of the substrate12′ are adhered to tissue adjacent (i.e., next to) to the wound edges102, as depicted in FIG. 2b and FIG. 3, the inventive system 10 can beused to close the wound by re-approximating the wounded edges 102together. More specifically, the thread 14 is secured to a firstanchoring member 20 on one side of the wound (e.g., by tying it off onone of the anchoring members 20) and then passed to the other side ofthe wound where it is secured to/threaded through a second anchoringmember 20 on the other side of the wound 100 such that tension iscreated on the side of the first anchoring member 20 pulling the tissueof the subject towards the second anchoring member 20. The back andforth process is repeated using various anchoring members 20 on eitherside of the wound edges 102 and thread 14 to keep tension on the tissuesurrounding the wound 100, until the edges of the wound 102 are lined upand drawn or brought together, as depicted in FIG. 4a . Those skilled inthe art will appreciate that one advantage of the invention is thatinstead of directly pulling the wound edges 102 together, the system 10instead pulls the adjacent tissue, which in effect, pushes the woundedges 102 together. Thus, there is little to no additional localizedtrauma to the wound edges 102 in the present wound closure system 10.Additional lacing of the substrate can be performed as depicted in FIG.4b to further support the tissue and the substrate, for example, tomitigate shearing forces on the wound 100. Those skilled in the art willrecognize that the particular pattern of the sutureless method willdepend to a certain extent on the shape and location of the wound. Itwill also be appreciated that the substrate pieces 12′ can be “sutured”or laced together using a single continuous thread 14, or multiplethreads 14 that are tied off at various points in the threading process.It will also be appreciated that the thread 14 can be passed through asingle anchoring member 20 multiple times during the lacing process,which unlike a conventional suture, allows that single point to betethered and stabilized from multiple directions, reducing any singledirectional force/tension on the tissue at that spot. This isparticularly important, for example, in the tip of a v-shaped lacerationwhich must be pulled in several different directions to re-approximatethe tissue. With traditional suturing or staples, this small section oftissue is ordinarily fragile and prone to tearing and further trauma.Such trauma is avoided by the present invention.

A particular advantage of the present method and device is that itpermits eversion of inverted wound edges 102′ before drawing those edgestogether. With reference to FIG. 5a , many wounds involve at least oneinverted wound edge 102′. Those skilled in the art will recognize thatinverting suture patterns are often associated with delayed healing.Thus, appositional or everting sutures are preferred for many tissueclosure as they provide the best anatomical approximation of thedisrupted tissue planes. More recently, there has been a recognition ofa benefit for a slight eversion on skin closures, because the scar has atendency to flatten rather than widen. Therefore, as depicted in FIG. 5b, in one or more embodiments, the thread 14 can be secured to ananchoring member 20 proximate to an inverted wound edge 102′, and thendrawn away from and secured to an anchoring member 20 distal from thewound edge 102′ (on that same side of the wound 100) to evert the edge102′. This procedure can be repeated as necessary or desired on alledges 102 of the wound 100 before subsequently drawing the edges 102together. Alternatively, if it is noticed that an edge of the wound 102has become inverted during the process of lacing together the substratepieces 12′, this same procedure can be used to evert the wound edge 102′from the closed wound 100′.

A further advantage of the system and method is that if theapproximation of the tissue during wound closure is not satisfactory,the thread 14 can simply be cut and removed from the anchoring members20 and the wound closure can be re-done without creating any additionaltrauma to the subject. This is particularly advantageous in cosmeticincision closure where scars and scarring should be minimized as much aspossible. It is not practical to remove and re-suture using traditionalsuturing or staple gun techniques because of the added trauma caused tothe subject and the tissue during such a process. Likewise, most woundclosure adhesives simply cannot be practically removed from the woundonce used to close the tissue. A further advantage is that because thistechnique is sutureless, removable, and “re-doable,” it can be used byunskilled persons to close a wound in emergency or short-term situationsand mediate further trauma and/or blood loss until the subject can beattended to by a medical practitioner. As noted above, the medicalpractitioner can then remove the threads and re-close the wound, ifnecessary. This would be particularly advantageous for home first aidkits, hikers, as well as for soldiers on the battle field.

The atraumatic wound closure system also reduces or even completelyeliminates the need for sedation and/or anesthesia, which can be animportant factor in treating pediatric and/or veterinary patients.Moreover, the wound itself remains visible for evaluation of infectionallowing for better local wound care and healing. The lack of sutures,staples, or other foreign bodies piercing the skin also reduces the riskof infection as well as promotes blood flow (and accordingly healing).In addition, if the wound does become infected, the present method ofwound closure allows for easier egress of purulent fluid and materialfrom the wound.

A kit for the atraumatic closure of wound tissue is also providedherein. The kit comprises one or more substrates as described above,optionally thread for lacing together the substrates, and instructionsfor using the substrate and thread to close a wound. Template materialcan also be included in the kit, along with scissors or other devicesfor cutting the substrate to fit the wound shape. Additionalconventional first-aid components, such as disinfectant, antibioticointment, alcohol, betadine, chlorhexidine, and the like can also beincluded in the kit.

It will be appreciated that the wound closure system described hereinmay be used, in one or more embodiments, in addition to traditionalwound closure techniques to further stabilize and support the tissueadjacent (i.e., next to) to the wound. The system could be used beforetraditional wound closure to facilitate pushing the disrupted tissueplanes together for traditional suturing, etc. Alternatively, the systemcould be applied after traditional wound closure to relieve pressure ortension on the wound edges due to the conventional sutures, staples,etc. used to close the wound. In other embodiments, the system is usedentirely in lieu of conventional wound closure techniques. Thus, thetissue of the subject is not pierced (by suture, staple, etc.) before,during, or after the process of reapproximating the wound edges usingthe inventive system.

It will also be appreciated that, instead of securing wound edges toclose a wound, the present system could also be used to secure medicaldevices, packing, dressings, and the like to a patient without piercingthe subject's tissue. For example, in one or more embodiments, theinvention is also concerned with atraumatic securement of a medicaldevice to a patient. The method comprises inserting a medical device 200into the patient and securing the device to the patient's tissue usingthe wound care system 10. In particular, one or more pieces of thesubstrate 12′ are adhered to tissue on either side of the device 200, asdepicted in FIGS. 7a and b. The device 200 is then secured to thesubstrate 12′ using the thread 14, which is secured between any suitableattachment points 202 on the device 200 and the anchoring members 20.For example, the thread 14 can be secured to a first anchoring member 20on one side of the device 200 (e.g., by tying it off on one of theanchoring members 20) and then passed to an attachment point 202 on thedevice before being passed to the other side of the device 200 where itis secured to/threaded through a second anchoring member 20 on the otherside of the device 200 such that tension is created on both sides of thedevice 200 to hold it in place. The back and forth process can berepeated using various anchoring members 20 on either side of the device200 until sufficiently secured in place to avoid being dislodged. Itwill be appreciated that the device 200 can be secured using a singlecontinuous thread 14, or multiple threads 14 that are tied off orfastened at various points in the threading process. It will also beappreciated that the thread 14 can be passed through a single anchoringmember 20 multiple times during the lacing process, which unlike aconventional suture, allows that single point to be tethered andstabilized from multiple directions, reducing any single directionalforce/tension on the tissue at that spot. Those skilled in the art willalso appreciate that one advantage of the invention is that there islittle to no additional localized trauma to the patient to secure thedevice, which can be easily removed by cutting or removing the thread14. The method would be suitable for securing various devices to apatient, include tracheal tubes, nasogastric tubes, ventilators, drains,catheters, IVs, central lines, arterial lines, and the like.

In one or more embodiments, the system 10 can be used to secure woundpacking and dressings. This is particularly advantageous for packingsthat need to be removed and replaced daily or multiple times per day,and avoids the repeat trauma to the patient that is encountered byrepeated application and removal of dressing tape and other similarcoverings. One or more pieces of the substrate 12′ can be adhered totissue adjacent (i.e., next to) the wound 100 which has been packed withsuitable packing material (e.g., sterile gauze, etc.) 200. Typically,the “tail” of the packing material 200 remains outside of the wound tofacilitate removal of the packing In the present system 10, the tail canadvantageously be secured to the substrate 12′ using the thread 14. Adressing 204 is then placed over the packed wound, and the system 10 isused to secure the dressing over the wound using the thread 14 and theanchoring members 20, as depicted in FIGS. 8a and 8b . The wound caresystem 10 can also be used to secure bolster dressings or other likedressings in a similar manner, as depicted in FIG. 9, which are oftenused with burn wounds and skin grafts, and are typically sutured to theskin, again creating additional trauma on the patient. In one or moreembodiments, the system 10 can also be used as part of a pressuredressing to stop bleeding and temporarily stabilize the patient untildefinitive care can be obtained, as depicted in FIG. 10. Thus, thesystem is suitable for use with various wound dressings, such as cotton4×4, and the like. It will be appreciated that in each of the foregoingwound care methods, the system 10 has an additional benefit ofsignificance to patient care. After the applicable dressing, packing, orthe like is removed from the patient at the appropriate stage of healing(i.e., by cutting or removing the thread 14 to permit removal of thecare device), the substrate can remain in place adjacent (i.e., next to)the wound. Using thread, the system can then be used to subsequentlyclose the wound for permanent healing. Again, the system provides asignificant advantage in that the tissue adjacent (i.e., next to) thewound does not have to undergo additional trauma from the applicationand/or removal of tape, adhesives, and the like, to remove thedressings, packing, etc., and does not have to be pierced or puncturedusing staples or suture to subsequently close the wound. This providesan important advancement in the state of the art of wound care andclosure.

The present substrate also finds usefulness as a novelty item. Forexample, the substrate described above can also be used to repair orclose ripped seams or other tears in stuffed animals. It will beappreciated that the substrate 12 will comprise an adhesive layersuitable for bonding to a fabric and/or synthetic “fur” surface. Thus,considerations as noted above with respect to biocompatibility will notbe as much of a factor in such an embodiment; however, the method of useremains substantially the same as that described above for woundclosure. The substrate could be provided, for instance, as part of ateddy bear repair kit. The thread would be provided generally without aneedle, such that the kit would be suitable for use by children torepair their stuffed animals. The kit would also be suitable for use aspart of a children's doctor set for pretend suturing of “patients.”

Additional advantages of the various embodiments of the disclosure willbe apparent to those skilled in the art upon review of the disclosureherein and the working examples below. It will be appreciated that thevarious embodiments described herein are not necessarily mutuallyexclusive unless otherwise indicated herein. For example, a featuredescribed or depicted in one embodiment may also be included in otherembodiments, but is not necessarily included. Thus, the presentinvention encompasses a variety of combinations and/or integrations ofthe specific embodiments described herein.

In addition, while the drawings illustrate, and the specificationdescribes, certain preferred embodiments, it is to be understood thatsuch disclosure is by way of example only. Embodiments are describedherein with reference to illustrations of idealized embodiments of thepresent invention. As such, variations from the shapes of theillustrations as a result, for example, of manufacturing techniquesand/or tolerances, are to be expected. There is no intent to limit theprinciples of the present embodiments to the particular disclosedembodiments. For example, in the drawings, the size and relative sizesof components may be exaggerated for clarity. In addition, embodimentsshould not be construed as limited to the particular shapes of regionsillustrated herein but are to include deviations in shapes that result,for example, from manufacturing.

As used herein, the phrase “and/or,” when used in a list of two or moreitems, means that any one of the listed items can be employed by itselfor any combination of two or more of the listed items can be employed.For example, if a composition is described as containing or excludingcomponents A, B, and/or C, the composition can contain or exclude Aalone; B alone; C alone; A and B in combination; A and C in combination;B and C in combination; or A, B, and C in combination. The term“adjacent” means adjoining, abutting (touching) so as to have a commoninterface/surface or border. In the case of layers, a layer isconsidered to be adjacent when it shares a common interface(i.e., is inface-to-face contact) with the adjacent structure. With respect to woundtissue, tissue that is adjacent to the wound refers to tissue proximateto the wound but not involving the wound edges (i.e., tissue spacedslightly from the wound edges themselves).

The present description also uses numerical ranges to quantify certainparameters relating to various embodiments of the invention. It shouldbe understood that when numerical ranges are provided, such ranges areto be construed as providing literal support for claim limitations thatonly recite the lower value of the range as well as claim limitationsthat only recite the upper value of the range. For example, a disclosednumerical range of about 10 to about 100 provides literal support for aclaim reciting “greater than about 10” (with no upper bounds) and aclaim reciting “less than about 100” (with no lower bounds).

What is claimed:
 1. An article for the atraumatic care and/or closure ofa tissue wound of a subject, or closure of ripped or torn fabric, saidarticle comprising: a substrate having opposing first and second majorsurfaces, wherein said substrate is a continuous, flexible web having asubstantially uniform thickness; a plurality of raised anchoring membersdisposed substantially uniformly across said first major surface andhaving a density in a first portion of the first major surface that issubstantially equivalent to the density of anchoring members in a leasta second, different portion of the first major surface such that theplurality of raised anchoring members are configured to distributepulling forces across the first major surface, said anchoring membersconfigured to secure a thread; and an optional adhesive adjacent saidsecond major surface.
 2. The article of claim 1, wherein said substratehas an average thickness of from about 1 mil to about 10 mils.
 3. Thearticle of claim 1, wherein said substrate is severable.
 4. The articleof claim 1, wherein said substrate comprises a woven or nonwoven web ofcotton, silk, hemp, flax, rayon, polyester, acrylic, acrylate,polyolefin, nylon, polyurethane, polyethylene, polyester, wire, and/orembedded wire clothe.
 5. The article of claim 1, wherein said anchoringmembers are selected from the group consisting of loops, half-loops,eyelets, mesh, hooks, pegs, prongs, nubs, generally upright strands offiber, prone strands of fiber, pleats, and combinations thereof.
 6. Thearticle of claim 1, wherein said adhesive is present adjacent saidsecond major surface and is in the form of a layer adjacent said secondmajor surface.
 7. The article of claim 6, wherein said adhesive whenpresent is selected from the group consisting of pressure sensitiveadhesives, heat-activated adhesives, and radiation-activated adhesives.8. The article of claim 6, wherein said adhesive comprises rubberelastomers, acrylics, silicones, zinc oxides, or a combination thereof.9. The article of claim 6, further comprising a releasable lineradjacent to and covering said adhesive.
 10. The article of claim 1,wherein said plurality of anchoring members are disposed substantiallyuniformly across said first major surface in a grid or matrix pattern.11. A system for atraumatic wound care and/or closure of a tissue woundof a subject, or closure of ripped or torn fabric, said systemcomprising: an article according to claim 1; and a thread configured tobe secured to one or more of the anchoring members of said article. 12.The system of claim 11, wherein said thread comprises nylon, polyester,polypropylene, silk, wire, plastic, cable, or a combination thereof. 13.The system of claim 11, wherein said thread comprises a substantiallyrigid end portion.
 14. The system of claim 11, further comprising aneedle configured to guide said thread.
 15. The system of claim 11,wherein when said article does not comprise adhesive adjacent saidsecond major surface, said system further comprising an adhesive formounting said article to tissue or fabric.
 16. A method of evertingtissue of a wound of a subject, said wound having wound edges and tissueadjacent said wound edges on a first side of said wound and on a secondside of said wound opposite said first side, said method comprising:providing an article according to claim 1 and a thread; adhering saidarticle substrate to said tissue adjacent said wound edge on said firstside of said wound; and everting said wound edge on said first side ofsaid wound by: securing a thread to a first anchoring on said first sideof the wound proximate to said wound edge; drawing said thread away fromsaid wound edge; and securing said thread to a second anchoring memberon said first side of the wound distal from said wound edge, said threadbeing under tension and pulling said wound edge on said first side ofsaid wound away from said tissue on said second side of said woundthereby everting said wound edge.
 17. The method of claim 16, whereinsaid securing each comprises tying said thread into a knot around saidfirst and second anchoring members, respectively.
 18. The method ofclaim 16, further comprising: adhering said article substrate to saidtissue adjacent said wound edge on said second side of said wound; andeverting said wound edge on said second side of said wound by: securinga thread to a first anchoring on said second side of the wound proximateto said wound edge; drawing said thread away from said wound edge; andsecuring said thread to a second anchoring member on said second side ofthe wound distal from said wound edge, said thread being under tensionand pulling said wound edge on said second side of said wound away fromsaid tissue on said first side of said wound thereby everting said woundedge.